fda 510k

December 16, 2015

FDA 510k & CE Marking

Medical Device Regulation in USA is formulated and controlled by FDA via Section 510k of the act. However, in Europe its via MDD directive so called CE Marking Reading this article will help those unfamiliar with 510k and  CE marking effectively prioritize their regulatory efforts. 510(k) is the preferred route to reach the Largest single market (USA) whereas CE Marking is the preferred route to reach 37 European counties and very interestingly it is widely accepted […]